The aim of these articles is to keep our Clients and Associates updated about developments in the sector of Intellectual Property in general and our firm in particular. In this way, we wish to provide a broader view of the tools that the field of trade marks, domain names, patents, designs and related rights offers to entrepreneurs to enhance and protect their efforts in researching and developing new solutions and ideas.
The New EU Regulation on New Genomic Techniques (NGTs): Between Agritech Innovation and the Patentability Issue
On 17 June 2026, the European Parliament gave its final approval to the new Regulation (2026/1388) on plants obtained through certain New Genomic Techniques (NGTs)—commonly referred to in Italy as Assisted Evolution Technologies (TEAs)—and their derived products.
This news marks a major turning point for the European agrifood and biotechnology sectors. After more than two decades under a rigid and widely deemed obsolete regulatory framework (the historic 2001 GMO Directive), the European Union is executing a decisive shift. The explicitly strategic objective is to reconcile environmental sustainability and climate change adaptation with the scientific and economic competitiveness of the EU agricultural sector.
Beyond its agronomic and commercial impact, this new framework provides an essential occasion for reflection for companies, research centers, and Intellectual Property professionals. Indeed, the reform not only redefines the authorization process for these plants, but also directly impacts the delicate balance between patent protection, plant variety rights, and the freedom to use agricultural raw materials.
An Obsolete Regulatory Context: Why Reform Was Urgent
To appreciate the scope of the new European text, one must recall how NGT regulation had hitherto been stymied by a restrictive judicial interpretation. In 2018, a landmark judgment by the Court of Justice of the European Union (CJEU) ruled that plants obtained through targeted mutagenesis (such as the CRISPR-Cas9 gene-editing technique) had to be fully assimilated to first-generation transgenic GMOs.
This classification entailed the maximum application of the precautionary principle, imposing extremely burdensome authorization procedures, prohibitive compliance costs, and making open-field trials in the EU virtually impossible.
However, scientific reality demonstrates a clear distinction:
- Traditional GMOs (Transgenesis): Involve the insertion, into the host genome, of DNA from sexually incompatible species.
- NGTs / TEAs (Cisgenesis and Targeted Mutagenesis): Carry out precise modifications by introducing sequences from the same species or inducing mutations entirely analogous to those that could occur naturally or through traditional breeding methods.
Continuing to treat precision genomic innovation in the same manner as early 1990s genetic manipulations would have condemned Europe to technological backwardness compared to dynamic markets such as the United States, Japan, and the United Kingdom.
Key Aspects of the Regulation: A Two-Tiered Approach
The approved text introduces a fundamental distinction based on the extent and nature of the genetic modification introduced into the plant:
- Category 1 NGT Plants (NGT-1): Plants featuring limited modifications (up to a maximum of 20 genetic alterations) that are considered equivalent to those obtainable through conventional methods. These plants are exempted from the constraints of GMO legislation: they do not require a complex risk assessment and are not subject to mandatory GMO consumer labeling on the final product (although transparency obligations remain for reproductive material, such as seed bags, along with registration in a public database).
- Category 2 NGT Plants (NGT-2): Encompass all other, more complex or extensive modifications. These varieties remain subject to an adapted and streamlined version of the GMO regime, requiring a prior risk assessment and full traceability along the entire supply chain.
An absolute threshold remains: no NGT plant may be used in organic agriculture, and plant varieties engineered to be herbicide-tolerant automatically fall under Category 2, regardless of the number of modifications performed.
The Patent Focus: A Complex Balance Between Protection and Accessibility
It is in the realm of Intellectual Property that the regulation sparked the most intense technical and political debate. How can the fundamental right of inventors and biotech companies to recoup substantial R&D investments be balanced against the need for farmers and conventional breeders to access genetic resources?
The European text establishes a compromise based on specific boundaries regarding patentability:
- 1 - Patentability of Technology vs. Exclusivity over Natural Traits
The regulation clarifies that technological innovation is patentable (e.g., a specific sequence modified via CRISPR or a particular editing process), but genetic sequences or traits already existing in nature or obtainable through traditional breeding methods cannot be patented. The objective is to prevent the "privatization" of biodiversity and technological lock-in by major seed conglomerates.
- 2 - Relationship with Plant Variety Rights (CPVRs)
Two systems traditionally coexisted in Europe: patents (for biotechnological inventions) and Community Plant Variety Rights (CPVRs)—managed by the Community Plant Variety Office (CPVO)—which guarantee the breeder’s exemption (the right of third parties to use a protected variety to breed new ones without prior authorization).
The new regulation seeks to prevent legal friction: where an NGT variety incorporates a patent-protected modification or trait, clauses are introduced to safeguard the use of resources for subsequent breeding activities by placing limitations on the scope of product claims.
- 3 - Safeguarding the "Farmer’s Privilege"
The right of farmers to save and reuse harvested seed or propagating material on their own holdings is formally protected, preventing overriding patent protection on the genetic modification from nullifying long-standing statutory exceptions for direct farming operations.
Implications for Corporate Patent Portfolio Management
The EU Regulation of 17 June 2026 demonstrates that protecting biotechnology innovations requires a comprehensive strategic perspective.
- Targeted Filing Strategies: Agritech companies will need to structure their patent applications with heightened focus on claim drafting. It will be essential to clearly delineate the novel feature introduced via NGTs from pre-existing or natural germplasm characteristics.
- Integration Between Patents and Plant Variety Rights: IP strategies can no longer rely solely on patents. Constructing an integrated IP architecture that combines patent protection for technology/gene-editing with plant variety rights will be essential.
- Transparency Monitoring and Freedom to Operate (FTO): The establishment of a central public EU register for NGT-1 products offers dual strategic protection. On the one hand, it mandates the disclosure of existing or pending patents related to the modified genetic trait, enabling companies to conduct significantly faster and more accurate Freedom to Operate (FTO) analyses to avoid inadvertent infringement during breeding. On the other hand, it ensures full transparency across the supply chain, providing breeders and farmers (particularly in the organic and GM-free sectors) with an official tool to verify variety origins and freely plan their commercial choices.
In conclusion, the framework established for NGTs offers extraordinary opportunities for growth, but demands meticulous legal and regulatory planning from the earliest stages of germplasm research. Transparency regarding plant variety rights and patents will be the key determinant for success in the new single market.
Our firm remains at your disposal to discuss your Clients’ specific needs and provide tailored advice on protecting their biotechnological inventions.